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NOVA Lite® ANCA (Formalin) Kit with DAPI

INOVA DIAGNOSTICS, INC. · Model 708300 · UDI-DI 08426950602118

MOB Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

"1 .20x ANCA (Formalin Fixed Human Neutrophil), slides - 12 wells 2. 1x 15mL FITC IgG Conjugate with DAPI 3. 1x 0.5 mL cANCA Positive 4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control 6. 2x25mL PBS II Concentrate (40x) 8. 1x 7mL Mounting Medium 9. 1x 20 Coverslips 10. 1x Direction Insert "

Recalls

Date	Firm	Reason
2023-05-24	Phadia Ab	Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA w

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.